Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Laryngeal Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Cisplatin

Participants will receive 3 cycles of oral solution of Xevinapant (Debio 1143) at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of Xevinapant (Debio 1143) at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Xevinapant (Debio 1143)

Participants will receive 66 Gy of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week.

IMRT

Participants will receive 3 cycles of oral solution of placebo matched to Xevinapant (Debio 1143) once daily from Day 1 to 14 per 3-week cycle in combination with radiotherapy followed by 3 cycles of monotherapy of placebo matched to Xevinapant (Debio 1143) from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Placebo

US Medical Information

Communication Center

James Bonner

Robert Haddad

Ammar W Sukari

Rafi Kabarriti

Zujun Li

Sara A Medek

Robert Ferris

Richard O Neal

Diego Lucas Kaen

Jorge Emilio Salinas

Alejandro Sola

Ruben D Kowalyszyn

Martin Burian

Richard F Greil

Tatiana Dragan

Jean Pascal Machiels

Marika Rasschaert

Willem Lybaert

Carlos E Baston Silva

Fabrício Augusto Martinelli de Oliveira

Fabricio Pontes Grando

Iane F Pinto Figueiredo Lima

Fabio André Franke

Rivadavio Antunes Menacho de Oliveira

Silvio C Sales

Alan Arrieira Azambuja

Sergio Jobim de Azevedo

Katsuki Arima Tiscoski

Pedro Rafael Martins De Marchi

Jamille G Dutra

Daniel O Brito

Claudia Vaz de Melo Sette

Lucas Vieira dos Santos

Milena Perez Mak

Denis Soulieres

Yan Sun

Yajun Zhang

Xin Jiang

Yaqian Han

Liangfang Shen

Mei Feng

Lei Liu

Yue Xie

Shaojun Lin

Shaoxiong Wu

Xiaonan Sun

Xianzhong Chen

Jin Gao

Man Hu

Jingao Li

Jing Yan

Song Qu

Chaosu Hu

Pin Dong

Caigang Liu

Peiguo Wang

Kunyu Yang

Hongbing Ma

Buhai Wang

Hui Wu

Bohuslav Melichar

Katerina Lickova

Petra Holeckova

Aurore Goineau

Amaury Daste

Ulrike Schick

Juliette Thariat

Noemie Vulquin

Matthieu Bosset

Yoann Pointreau

Xavier Liem

Christian Sire

Ariane Lapierre

Sebastien Salas

Pierre Boisselier

Alexis Lenglet

Esma Saada-Bouzid

Valentin Calugaru

Florence Huguet

Camille Evrard

Sebastien Thureau

Francois Georges Riet

Frederic Rolland

Christian Borel

Xavier Tchiknavorian

Anouchka Modesto

Sophie Chapet

Yungan Tao

Tamta Makharadze

Eter Natelauri

Amiran Matitashvili

Miranda Gogishvili

Tamar Melkadze

Davit Giorgadze

Maike de Wit

Christine Langer

Rami El Shafie

Medical Responsible

The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

A Randomized, Double-blind, Placebo-controlled, 2-arm Phase III Study to Assess Efficacy and Safety of Xevinapant and Radiotherapy Compared to Placebo and Radiotherapy for Demonstrating Improvement of Disease-free Survival in Participants With Resected Squamous Cell Carcinoma of the Head and Neck, Who Are at High Risk for Relapse and Are Ineligible for High-dose Cisplatin (XRAY VISION)

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Merck KGaA, Darmstadt, Germany

EMD Serono Research & Development Institute, Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Renal Insufficiency

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Gemcitabine

Carboplatin

Tubulin Modulators

Vinblastine

Antimetabolites

Antimitotic Agents

* Vinflunine 280 or 250 mg/m2, IV administration over 20 minutes (starting dose based on baseline creatinine clearance value), Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal
* Gemcitabine 750 or 1000 mg/m2, IV administration over 30 minutes (starting dose based on baseline creatinine clearance value), Day 1 and 8 every 3 weeks up to progression or unacceptable toxicity or patient's refusal

Vinflunine, Gemcitabine

* Vinflunine 280 or 250 mg/m2, IV administration over 20 minutes (starting dose based on baseline creatinine clearance value), Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal
* Carboplatin AUC 4.5, IV administration over 60 minutes, Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal

Vinflunine, Carboplatin

Maria De Santis, MD

Stéphane Culine, MD

This study is assessing the combination of well known cytotoxics with a novel anti-cancer agent that could be administered as monotherapy without renal toxicity in patients with renal impairment presenting with advanced or metastatic urothelial carcinoma previously treated with a platinum-based regimen. The intent of this study is to clarify the benefit/risk ratio of the two most promising associations of cytotoxics including the novel therapeutic agent, vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.

Gemcitabine and carboplatin have been the most studied and used anticancer agents in cisplatin-unfit patients with advanced urothelial carcinoma. Both agents previously demonstrated clinical activity as single agent and/or as part of combination regimen in patients with advanced or metastatic disease even if clinical benefits and survival remains limited in this setting for this population.

The purpose of this study is to test in a randomized trial enrolling patients with renal impairment or moderate congestive heart failure two combinations of a novel cytotoxic agent, vinflunine, one with gemcitabine and another with carboplatin in order to determine the most promising combination in the first line treatment of advanced/metastatic urothelial carcinoma.

JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin

Randomized Phase II Study Assessing the Combination of Vinflunine With Gemcitabine and Vinflunine With Carboplatin in Patients Ineligible to Cisplatin With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

Assessment of lesions (measurable and non-measurable) should be performed at baseline and every 6 weeks (assessment interval).

Evaluable patients: all baseline lesions must have been assessed at least once after the second cycle (6 weeks); patients who progress before the first evaluation will be considered as early progression.

Primary analysis is planned on the intent to treat population, secondary analysis being performed on the evaluable population.

Assessment of lesions (measurable and non-measurable) should be performed at baseline and every 6 weeks (assessment interval).

Evaluable patients: all baseline lesions must have been assessed at least once after the second cycle (6 weeks); patients who progress before the first evaluation will be considered as early progression.

Tumor assessment at baseline and then every 6 weeks, until tumor progression. Duration of disease control according to investigator will be calculated among the responders and stable patients from the date of randomisation until the documentation of progression or death due to any cause. Patients who are lost to follow-up without progression, or reach the time point of analysis without a known record of progression or death will have the duration of disease control censored at the date of last tumour assessment or last contact of a follow-up showing no progression, whichever occur last.

Tumor assessment at baseline and then every 6 weeks, until tumor progression. Duration of response will be calculated among the responders (i.e. CR and PR) . Patients who are lost to follow-up, or reach the time point of analysis without a known record of progression or death will have the duration of response censored at the date of last tumour assessment or last contact of a follow-up showing no progression, whichever occur last.

Tumor assessment at baseline and then every 6 weeks. Will be calculated among the responders (i.e. CR and PR)

Tumor assessment (RECIST) every 6 weeks. Patients who reach the time point of analysis without failure as defined above will have the time to treatment failure censored at the date of last tumour assessment or last contact of a follow-up not showing progression. Patients who discontinued treatment for other reason and who are lost to follow-up will be censored at the date of last contact.

Tumor assessment every 6 weeks (RECIST).Patients who are lost to follow-up, or reach the time point of analysis without a known record of progression or death will have the progression-free survival censored at the date of last tumour assessment or last contact of a follow-up showing no progression, whichever occur last.

Data recording every 3 months. For patients who have not died, survival time will be censored at the date of last news (i.e: date of last administration, tumor assessment, clinical examination, haematological or biochemistrical assessment or date of last contact).

Population: all treated patients unless the patient is lost to follow-up immediately after the start of the treatment. The patients will be analysed in the treatment arm they actually received.

The NCI-CTC classification version 2.0 will be used to classify toxicities. Maximum grade or severity will be reported by cycle and by patient for each MedDRA Preferred Term. Analyses will be performed both regardless the relationship to treatment and related to treatment.

Biochemical toxicities: the worst CTCAE version 2.0 grade will be analysed according to the grade present at baseline.

Pierre Fabre Medicament

Blood and Lymph Conditions

Immune System Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antirheumatic Agents

Rituximab

Loncastuximab tesirine

Antineoplastic Agents, Immunological

Immunologic Factors

Participants who are unfit (per sGA) will receive Lonca-R for 3 cycles. Participants who achieve a complete response (CR) will receive Lonca-R for 1 additional cycle. Participants who achieve a partial response (PR) will receive Lonca-R for 3 additional cycles.

Lonca-R will be administered as rituximab 375 mg/m\^2 on Day 1 of Cycle 1 and loncastuximab tesirine 150 µg/kg on Day 2 of Cycle 1. During Cycle 2, Lonca-R will be administered as rituximab\* 375 mg/m\^2 and loncastuximab tesirine 150 µg/kg on Day 1. For cycles 3 and beyond, Lonca-R will be administered as rituximab 375 mg/m\^2 and loncastuximab tesirine 75 µg/kg on Day 1.

\*subcutaneous rituximab 1400mg/dose may be used during Cycle 2 and beyond

Participants who are frail (per sGA) or participants with cardiac comorbidities will receive Lonca-R for 3 cycles. Participants who achieve a CR will receive Lonca-R for 1 additional cycle. Participants who achieve a PR will receive Lonca-R for 3 additional cycles for a total of up to 6 cycles. Only participants enrolled in Cohort B, who achieve stable disease (SD) and deriving clinical benefit per the treating physician, may also receive Lonca-R for an additional 3 cycles.

Lonca-R will be administered as rituximab 375 mg/m\^2 on Day 1 of Cycle 1 and loncastuximab tesirine 150 µg/kg on Day 2 of Cycle 1. During Cycle 2, Lonca-R will be administered as rituximab\* 375 mg/m\^2 and loncastuximab tesirine 150 µg/kg on Day 1. For cycles 3 and beyond, Lonca-R will be administered as rituximab 375 mg/m\^2 and loncastuximab tesirine 75 µg/kg on Day 1.

\*subcutaneous rituximab 1400mg/dose may be used during Cycle 2 and beyond

Loncastuximab Tesirine

Cycle 1 - Intravenous (IV) Infusion. Cycle 2+ - Intravenous (IV) Infusion or Subcutaneous (SC) Administration.

The main objective of the trial is to assess the efficacy and tolerability of Lonca-R in unfit and frail participants with previously untreated DLBCL.

The primary objectives of this trial are shown below:

Cohort A: To assess the efficacy of a response-adapted treatment of Lonca-R in unfit participants with previously untreated DLBCL, high-grade B cell lymphoma (HGBCL), or Grade 3b follicular lymphoma (FL).

Cohort B: To assess the tolerability and efficacy of a response-adapted treatment of Lonca-R in frail participants with previously untreated DLBCL, or HGBCL, or Grade 3b FL who are ineligible for standard R-mini-CHOP.

The simplified geriatric assessment (sGA) developed by the Fondazione Italiana Linfomi (FIL) identifies three distinct categories (fit, unfit, and frail) based on age, activities of daily living (ADL), instrumental activities of daily living (IADL) and the Cumulative Illness Rating Scale for Geriatrics (CIRS-G). Participants will be assigned to Cohort A (unfit) or B (frail) using the sGA.

A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)

A Phase 2 Open-label Study of Loncastuximab Tesirine in Combination With Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients With Diffuse Large B-cell Lymphoma (DLBCL) (LOTIS-9)

Includes frequency and severity of adverse events (AEs) and serious AEs (SAEs) that occur after study treatment administration. Clinically significant changes from baseline in safety laboratory variables, vital signs and physical examinations will also be recorded as TEAEs/SAEs.

ECOG performance status will be assessed on a 6-point scale ranging from 0 (fully active) to 5 (dead).

Includes changes in symptoms, functions and overall health status as measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym). The FACT-Lym is scored from 0-168 where a higher score indicates a worse outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)	NCT05386550	Head and Neck C...	Xevinapant (Deb... IMRT Placebo	18 Years -	EMD Serono
JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin	NCT01599013	Bladder Transit...	Vinflunine, Gem... Vinflunine, Car...	18 Years - 79 Years	Pierre Fabre Medicament
A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)	NCT05144009	Diffuse Large B...	Loncastuximab T... Rituximab	80 Years -	ADC Therapeutics S.A.
JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin	NCT01599013	Bladder Transit...	Vinflunine, Gem... Vinflunine, Car...	18 Years - 79 Years	Pierre Fabre Medicament
Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)	NCT05386550	Head and Neck C...	Xevinapant (Deb... IMRT Placebo	18 Years -	EMD Serono
Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia	NCT00636922	Acute Myeloid L...	RAD001(Everolim...	18 Years -	Bayside Health
Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia	NCT00636922	Acute Myeloid L...	RAD001(Everolim...	18 Years -	Bayside Health
Metronomic Temozolomide in Unfit NENs Patients Metronomic Temozolomide in Unfit Patients With Advanced Neuroendocrine Neoplasms (NENs): MeTe Study	NCT05554003	Neuroendocrine ... Frailty Chemotherapy Ef...	Temozolomide ca...	18 Years -	European Institute of Oncology
Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia	NCT00636922	Acute Myeloid L...	RAD001(Everolim...	18 Years -	Bayside Health

Spots Global Cancer Trial Database for unfit

Every month we try and update this database with for unfit cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for unfit

Every month we try and update this database with for unfit cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for unfit cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.